胚胎培养和形态动力学分析选择的临床验证：胚胎镜的随机对照试验。

Clinical validation of embryo culture and selection by morphokinetic analysis: a randomized, controlled trial of the EmbryoScope.

机构信息

Instituto Universitario IVI Valencia, University of Valencia, Valencia, Spain.

IVI Bilbao, Bilbao, Spain.

出版信息

Fertil Steril. 2014 Nov;102(5):1287-1294.e5. doi: 10.1016/j.fertnstert.2014.07.738. Epub 2014 Sep 11.

DOI:10.1016/j.fertnstert.2014.07.738

PMID:25217875

Abstract

OBJECTIVE

To determine whether incubation in the integrated EmbryoScope time-lapse monitoring system (TMS) and selection supported by the use of a multivariable morphokinetic model improve reproductive outcomes in comparison with incubation in a standard incubator (SI) embryo culture and selection based exclusively on morphology.

DESIGN

Prospective, randomized, double-blinded, controlled study.

SETTING

University-affiliated private in vitro fertilization (IVF) clinic.

PATIENT(S): Eight hundred forty-three infertile couples undergoing intracytoplasmic sperm injection (ICSI).

INTERVENTION(S): No patient intervention; embryos cultured in SI with development evaluated only by morphology (control group) and embryos cultured in TMS with embryo selection was based on a multivariable model (study group).

MAIN OUTCOME MEASURE(S): Rates of embryo implantation, pregnancy, ongoing pregnancy (OPR), and early pregnancy loss.

RESULT(S): Analyzing per treated cycle, the ongoing pregnancy rate was statistically significantly increased 51.4% (95% CI, 46.7-56.0) for the TMS group compared with 41.7% (95% CI, 36.9-46.5) for the SI group. For pregnancy rate, differences were not statistically significant at 61.6% (95% CI, 56.9-66.0) versus 56.3% (95% CI, 51.4-61.0). The results per transfer were similar: statistically significant differences in ongoing pregnancy rate of 54.5% (95% CI, 49.6-59.2) versus 45.3% (95% CI, 40.3-50.4) and not statistically significant for pregnancy rate at 65.2% (95% CI, 60.6-69.8) versus 61.1% (95% CI, 56.2-66.1). Early pregnancy loss was statistically significantly decreased for the TMS group with 16.6% (95% CI, 12.6-21.4) versus 25.8% (95% CI, 20.6-31.9). The implantation rate was statistically significantly increased at 44.9% (95% CI, 41.4-48.4) versus 37.1% (95% CI, 33.6-40.7).

CONCLUSION(S): The strategy of culturing and selecting embryos in the integrated EmbryoScope time-lapse monitoring system improves reproductive outcomes.

CLINICAL TRIAL REGISTRATION NUMBER

NCT01549262.

摘要

目的

与仅基于形态学的标准培养箱（SI）胚胎培养和选择相比，在集成胚胎观察系统（TMS）中孵育并通过使用多变量形态动力学模型进行选择是否能提高生殖结局。

设计

前瞻性、随机、双盲、对照研究。

地点

大学附属私立体外受精（IVF）诊所。

患者

843 对患有胞浆内精子注射（ICSI）的不孕夫妇。

干预

无患者干预；胚胎在 SI 中孵育，仅通过形态学评估（对照组），胚胎在 TMS 中孵育，胚胎选择基于多变量模型（研究组）。

主要观察指标

胚胎着床率、妊娠率、持续妊娠率（OPR）和早期妊娠丢失率。

结果

分析每个治疗周期，与 SI 组的 41.7%（95%置信区间，36.9-46.5）相比，TMS 组的持续妊娠率统计学上显著增加 51.4%（95%置信区间，46.7-56.0）。对于妊娠率，差异无统计学意义，分别为 61.6%（95%置信区间，56.9-66.0）和 56.3%（95%置信区间，51.4-61.0）。每个移植的结果相似：持续妊娠率的统计学显著差异为 54.5%（95%置信区间，49.6-59.2）与 45.3%（95%置信区间，40.3-50.4），妊娠率无统计学显著差异，分别为 65.2%（95%置信区间，60.6-69.8）与 61.1%（95%置信区间，56.2-66.1）。TMS 组的早期妊娠丢失率统计学显著降低，为 16.6%（95%置信区间，12.6-21.4），而 SI 组为 25.8%（95%置信区间，20.6-31.9）。种植率统计学显著增加，为 44.9%（95%置信区间，41.4-48.4）与 37.1%（95%置信区间，33.6-40.7）。